Impact of Topical Tranexamic Acid in Breast Reconstruction

The Impact of Tranexamic Acid in Reducing Hematoma and Seroma Formation in Reconstructive Post-oncologic Breast Surgery

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05807074

Enrollment

Registered

2023-04-10

Start date

2023-04-20

Completion date

2024-11-30

Last updated

2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast Reconstruction, Mastectomy

Brief summary

Improvement in bleeding and bruising has been described by using both intravenous and topical off-label applications of Tranexamic Acid (TXA) in many surgical fields. This trial tests how well applying tranexamic acid (TXA) to the surface of the surgical site (topically) works to reduce post-operative bleeding (hematomas) and fluid collections (seromas) in women undergoing surgery to remove both breasts (bilateral mastectomy) immediately followed by surgery to rebuild the breast (reconstruction). The formation of hematomas and seromas, a common post-mastectomy complication, can interfere with breast reconstruction and increase the risk of infection and wound healing and can potentially delay cancer treatments. TXA is a synthetic molecule that pushes the body's clotting cascade toward clot formation to improve blood clotting. Applying TXA topically to the surgical site before closing the incision may prevent hematoma and seroma formation in post-mastectomy breast reconstruction patients. Participants will be recruited from patients undergoing bilateral mastectomy at University of California, San Francisco.

Detailed description

PRIMARY OUTCOMES: I. To investigate whether topical tranexamic acid may impact rates of seroma, hematoma, severe bruising, and drain output in the post-mastectomy reconstructive population. II. To evaluate the impact of TXA on seroma rates compared to control. SECONDARY OUTCOMES: I. To evaluate the impact of TXA on patient and provider rating of bruising, comparing the TXA side to the control side. II. To evaluate the impact of TXA on total drain output in the first post operative day. III. To evaluate the impact of TXA on total drain duration. OUTLINE: Participants will only be treated intra-operatively at the time of surgery with topical TXA to one breast pocket. Each participant will serve as own internal control, with one side receiving saline and the other TXA. Participants in this study will be assessed at their regularly scheduled visits up to one year post-operatively.

Interventions

DRUGTranexamic Acid

Applied intraoperatively

OTHERSaline

Applied intraoperatively

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Histologically confirmed breast malignancy OR increased risk for breast cancer 2. Age \>= 18 years 3. Scheduled to undergo bilateral mastectomy with plastic surgery closure or reconstruction 4. Ability to understand a written informed consent document, and the willingness to sign it 5. At least 4 weeks post-completion of chemotherapy or radiation therapy

Exclusion criteria

1. Any significant medical condition or laboratory abnormalities, which places the subject at unacceptable risk if she were to participate in the study 2. Any history of thromboembolic disease 3. Current anticoagulant use 4. Current use of chlorpromazine due to label contraindication 5. Current use of any prothrombotic medical products due to label contraindication 6. Documented or reported allergic reaction to tranexamic acid 7. Male participants

Design outcomes

Primary

Measure	Time frame	Description
Number of Breast Pockets That Develop a Hematoma	Up to 1 month	Presence of hematoma in the surgical area within a 30-day period from time of treatment application in the operating room will be reported.
Number of Breast Pockets That Develop a Seroma	Up to 3 months	Presence of seroma in the surgical area within 3-month period from time of treatment application in the operating room will be reported.

Secondary

Measure	Time frame	Description
Median Total Drain Duration	Approximately 1 month	The median time of total drain duration from drain placement in the operating room to removal of the drain will be reported descriptively for the saline only and TXA treated breast.
Number of Breast Pockets That Developed Ecchymosis	Up to 1 year	Ecchymosis will be measured separately for the right and left breast pocket at each post operative visit and documented. The observer will be blinded to the laterality of TXA. Both participant and provider will be asked to rank which side, the right or left side, has worse bruising. The frequency of ecchymosis for the right and left side will be reported descriptively.
Proportion of Participants With Reported Infection in Surgical Area Post-mastectomy	Up to 1 year	The proportion of participants with demonstrated infection in surgical area related to the bilateral mastectomy will be reported.
Number of Participants Requiring Reoperation After Completion of Bilateral Mastectomy	Up to 1 year	The number of participants requiring an additional operation related to the bilateral mastectomy will be reported.
Median Total Drain Output	Approximately 1 month	Total drain output over the life of the drain from drain placement in the operating room to discharge on post-operation day 1. Drains will be removed per standard practice at our institution which is when they have produced \< 30 cubic centimeters (cc) per day for at least 3 days.

Countries

United States

Participant flow

Pre-assignment details

All participants received the same intervention to the same breast pocket during bilateral mastectomy surgery before the study was closed prematurely to enrollment.

Participants by arm

Arm	Count
All Participants Each participant received 20cc of dilute Tranexamic Acid (TXA) 25mg/ml solution in the pocket of the right breast during surgery and before wound closure and simultaneously administered 20 cubic centimeters (cc) of saline to the left breast pocket during surgery and before wound closure.	23
Total	23

Baseline characteristics

Characteristic	All Participants
Age, Customized 20-29 years old	4 Participants
Age, Customized 30-39 years old	4 Participants
Age, Customized 40-49 years old	10 Participants
Age, Customized 50-59 years old	5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	1 Participants
Race (NIH/OMB) Black or African American	2 Participants
Race (NIH/OMB) More than one race	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants
Race (NIH/OMB) White	18 Participants
Region of Enrollment United States	23 participants
Sex: Female, Male Female	23 Participants
Sex: Female, Male Male	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 23	0 / 23
other Total, other adverse events	3 / 23	3 / 23
serious Total, serious adverse events	0 / 23	0 / 23

Outcome results

Primary

Number of Breast Pockets That Develop a Hematoma

Presence of hematoma in the surgical area within a 30-day period from time of treatment application in the operating room will be reported.

Time frame: Up to 1 month